Quality Engineer - On site

JOB SUMMARY:

This position develops and executes validation protocols (IQ / OQ / PQ) as required for equipment, sanitization/cleaning, facilities, software, and processes. This job will also work with customers regarding customer-specific equipment and process validations.

ESSENTIAL ACCOUNTABILITIES:

Facilitate and maintain validation project documentation, including the Site Validation Master Plan.

Serve as the database administrator for Infinity QS (Statistical Process Control) software.

Provide statistical analysis support for manufacturing, new product development (NPD), trials and validation activities.

Develop SOPs relating to validation and risk management.

Monitor and prepare Key Performance Indicators (KPIs) for major customers.

Conduct quality/engineering studies to support manufacturing operations.

Facility Corrective Action / Preventive Action (CAPA) activities to identify and resolve root cause issues through sound investigation and effective problem-solving techniques within the manufacturing plant.

Facilitate and train associates on quality topics required for their positions (SPC / CAPA).

Coordinate continuous improvement initiatives alongside internal and external (customer or supplier) representatives.

Demonstrate commitment to the company's RRITE Values of Renew, Respect, Integrity, Teamwork, and Excellence.

Associates have a direct and important role in ensuring that all work is performed in a safe manner. Effectiveness in carrying out this responsibility is part of each associate's essential accountabilities.

Contribute to a cooperative working effort by demonstrating a willingness to perform other job-related work, as needed or requested.

QUALIFICATION REQUIREMENTS:

(To perform this job successfully, an individual must be able to perform each of the essential accountabilities satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.)

Bachelor's degree in Engineering, science or related field is required.

Three+ years of engineering experience, preferably in a manufacturing environment is required.

Experience in an FDA-regulated environment preferred.

Strong self-starter with the ability to work independently as well as collaboratively in a team setting with peers and colleagues in a cross-functional setting.

Demonstrated ability to perform technical Non-Conformance Investigations and Root Cause Analyses.

Ability to prioritize and handle multiple tasks; ability to meet deadlines in a fast-paced work environment.

Ability to have a flexible work schedule to support department projects and coordinate with production and validation schedules.

Technical background in nutritional products, laboratory diagnostics, medical devices, pharmaceutical or similar industry.

MUST HAVE:

Three+ years of engineering experience in a manufacturing environment is required.

Experience in an FDA-regulated environment preferred.

Must have Process Validation Experience